ADCE-D01 for Metastatic or Unresectable Soft Tissue Sarcoma
This study is testing a new treatment called ADCE-D01 for people with metastatic (spread to other parts of the body) or unresectable (cannot be removed by surgery) soft tissue sarcoma. ADCE-D01 is an antibody-drug conjugate (ADC), which means it combines an antibody (AB-004) with a cancer-fighting drug (P1021). The main goals are to find the safest and most effective dose of ADCE-D01 and to see how well it is tolerated. Researchers will also look at how effective ADCE-D01 is at shrinking tumors. You may be able to join if you are at least 18 years old, have soft tissue sarcoma that has spread or cannot be removed, and have received one or two prior treatments for your cancer. The study plans to enroll 270 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 270 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability will be assessed throughout the trial, with completion expected approximately 18 months from completed enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
At a glance
Conditions
Where it's being run
8 sites across 8 statesWho to contact
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What this trial measures
- Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)
Measuring incidence of dose-limiting toxicities (DLTs)
- Assess the safety and tolerability of ADCE-D01Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Nature, incidence, severity and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation.